Kite Pharma, Inc.
Kite Pharma, Inc. (Form: 8-K, Received: 05/08/2017 08:11:39)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported): May 8, 2017

 

 

Kite Pharma, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36508   27-1524986

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

2225 Colorado Avenue

Santa Monica, California

  90404
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (310) 824-9999

Not Applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 2.02 Results of Operations and Financial Condition.

On May 8, 2017, Kite Pharma, Inc. (“Kite”) announced its financial results for the first quarter ended March 31, 2017 in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by Kite under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d)  Exhibits.

The following exhibit is filed as part of this Current Report:

 

99.1    Press Release of Kite, dated May 8, 2017.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: May 8, 2017

   

KITE PHARMA, INC.

(Registrant)

   

By:

 

/s/ Paul Jenkinson

   

Name:

  Paul Jenkinson
   

Title:

  Chief Financial Officer


EXHIBIT INDEX

 

Exhibit

Number

   Description
99.1    Press Release of Kite, dated May 8, 2017.

Exhibit 99.1

Kite Reports First Quarter Financial Results

 

    Completed Submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Kite’s CAR-T Therapy, Axicabtagene Ciloleucel, in Patients with Aggressive Non-Hodgkin Lymphoma (NHL)

 

    Initiated Two New Clinical Studies as Part of an Expanded KTE-C19 Development Program

 

    Advanced Additional New Cell Therapy Candidates Toward Clinical Study in 2017

 

    Expanded Cell Therapy Account Management Capabilities in Anticipation of Potential Approval and Launch of Axicabtagene Ciloleucel

 

    Completed $409.7 Million Follow-On Offering of Common Stock

 

    Conference Call to Be Held Today at 5:30 AM PDT / 8:30 AM EDT

SANTA MONICA, Calif. May 8, 2017 - Kite Pharma, Inc. (Nasdaq:KITE), a cell therapy company, today reported first quarter 2017 financial results and provided a corporate update for the period ended March 31, 2017.

“Kite is intensely focused on bringing axicabtagene ciloleucel to market in 2017. Our preparation for the potential commercialization of the first CAR-T therapy in aggressive non-Hodgkin lymphoma began two years ago. With the team and infrastructure we now have in place, we are confident in our readiness to deliver upon potential approval in the U.S. and expect to file for approval in Europe in the third quarter of this year,” said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. “We are also keeping an eye toward future growth with additional indications across the KTE-C19 program and development of earlier stage product candidates, including KITE-585, which we believe has the potential to become the next significant opportunity for Kite.”

First Quarter 2017 Financial Results

 

    Revenues were $9.8 million for the first quarter of 2017.

 

    Research and development expenses were $65.9 million for the first quarter of 2017, which includes $12.7 million of non-cash stock-based compensation expense.

 

    General and administrative expenses were $35.8 million for the first quarter of 2017, which includes $11.4 million of non-cash stock-based compensation expense.

 

    Net loss was $90.4 million, or $1.74 per share, for the first quarter of 2017.

 

    Non-GAAP net loss for the first quarter of 2017 was $66.3 million, or $1.28 per share, excluding non-cash stock-based compensation expense of $24.1 million.

 

    As of March 31, 2017, Kite had $804.0 million in cash, cash equivalents, and marketable securities. A public offering of common stock generated approximately $409.7 million in gross proceeds to Kite. In addition, Kite received a $50 million upfront payment related to its strategic collaboration with Daiichi Sankyo.

2017 Financial Guidance

 

    Kite continues to expect the full year 2017 net cash burn to be between $325 million and $340 million. This guidance assumes GAAP operating expenses to be between $490 million and $515 million, which includes approximately $135 million in non-cash stock based compensation expense. Kite expects 2017 total operating expenses to consist of approximately 60 percent Research and Development and approximately 40 percent General and Administrative.

 

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First Quarter 2017 and Recent Highlights

Axicabtagene Ciloleucel/KTE-C19 Progress

 

    Presented positive topline results from the primary analysis of the ZUMA-1 study of axicabtagene ciloleucel in patients with aggressive non-Hodgkin lymphoma (NHL) at the 2017 American Association of Cancer Research annual meeting. Data included the 99 percent success rate in the manufacturing of clinical product patient dose from a single apheresis for the multi-center ZUMA-1 clinical trial.

 

    Completed the submission of a Biologics License Application (BLA) to the FDA for axicabtagene ciloleucel in patients with aggressive NHL.

 

    Initiated ZUMA-5 study of axicabtagene ciloleucel in patients with follicular NHL.

 

    Initiated ZUMA-9 study to provide patients access to axicabtagene ciloleucel during the regulatory review period.

Strategic Collaborations

 

    Entered a strategic collaboration with Daiichi Sankyo to develop and commercialize axicabtagene ciloleucel in Japan.

 

    Established a joint venture with Fosun Pharma to develop and commercialize T-cell therapies, including axicabtagene ciloleucel, in China.

Pipeline Expansion

 

    Cleared an investigational new drug (IND) application for KITE-718, a T cell receptor (TCR) cell therapy candidate that targets MAGE-A3/A6 antigens expressed on solid tumors.

Commercial Preparation

 

    Started recruitment and training of cell therapy account managers to support customer service and logistical coordination.

Additional 2017 Clinical Milestones

KTE-C19 and axicabtagene ciloleucel

 

    Submit marketing authorization application (MAA) to the European Medicines Authority (EMA) for axicabtagene ciloleucel in aggressive NHL in the third quarter of 2017.

 

    Availability of preliminary 12-month follow-up data from ZUMA-1 study of axicabtagene ciloleucel in patients with aggressive NHL.

 

    Availability of preliminary follow-up Phase 1 data from ZUMA-3 and ZUMA-4 studies of pediatric and adult acute lymphoblastic leukemia, respectively.

 

    Advance ZUMA-3 and ZUMA-4 studies into Phase 2.

 

    Availability of preliminary data from ZUMA-6 combination study of axicabtagene ciloleucel and atezolizumab PD-L1 checkpoint inhibitor in aggressive NHL.

Cell Therapy Pipeline

 

    Initiate Phase 1 study of KITE-718 in patients with solid tumors in the second quarter of 2017.

 

    File IND for KITE-585, a CAR T cell therapy candidate that targets BCMA for the treatment of multiple myeloma in the third quarter of 2017.

 

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About Kite

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “expected,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and timing of obtaining regulatory approval based on the studies of axicabtagene ciloleucel, commercially launching axicabtagene ciloleucel, submitting an MAA to the EMA for axicabtagene ciloleucel, and researching and developing additional product candidates, including KITE-718 and KITE-585, and meeting the additional 2017 clinical milestones, and Kite’s 2017 financial guidance. Various factors may cause differences between Kite’s expectations and actual results as discussed in greater detail in Kite’s filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended March 31, 2017. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Conference Call and Webcast Details

Kite will host a live conference call and webcast today at 5:30 AM Pacific Time (8:30 AM Eastern Time) to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 888-771-4371 (U.S.) or 847-585-4405 (International). The conference ID number for the live call is 44658201. The webcast will be made available on the Company’s website at www.kitepharma.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

 

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KITE PHARMA, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands)

 

     MARCH 31,
2017
(unaudited)
     DECEMBER 31,
2016
 

ASSETS

     

Current assets

     

Cash, cash equivalents, and marketable securities

   $ 804,028      $ 414,422  

Prepaid expenses and other current assets

     15,200        12,974  
  

 

 

    

 

 

 

Total current assets

     819,228        427,396  

Restricted cash and investments

     17,883        10,669  

Property and equipment, net

     46,241        44,409  

Intangible assets and goodwill, net

     30,873        31,398  

Other assets

     9,518        10,432  
  

 

 

    

 

 

 

Total assets

   $ 923,743      $ 524,304  
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities

     

Accounts payable

   $ 13,214      $ 10,660  

Accrued expenses and other current liabilities

     26,492        29,482  

Deferred revenue

     39,886        15,000  
  

 

 

    

 

 

 

Total current liabilities

     79,592        55,142  

Deferred revenue, less current portion

     38,177        19,779  

Contingent consideration

     14,575        14,218  

Other non-current liabilities

     11,301        7,195  
  

 

 

    

 

 

 

Total liabilities

     143,645        96,334  

Total stockholders’ equity

     780,098        427,970  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 923,743      $ 524,304  
  

 

 

    

 

 

 

 

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KITE PHARMA, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(unaudited)

 

     THREE MONTHS ENDED
MARCH 31,
 
     2017     2016  

Revenues

   $ 9,836     $ 5,127  

Operating expenses:

    

Research and development

     65,906       34,414  

General and administrative

     35,842       16,683  
  

 

 

   

 

 

 

Total operating expenses

     101,748       51,097  
  

 

 

   

 

 

 

Loss from operations

     (91,912     (45,970

Interest income

     1,028       816  

Interest expense

     (4     —    

Other income (expense)

     428       29  
  

 

 

   

 

 

 

Loss before income taxes

     (90,460     (45,125

Benefit from income taxes

     61       1,209  
  

 

 

   

 

 

 

Net loss

   $ (90,399   $ (43,916
  

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (1.74   $ (0.90
  

 

 

   

 

 

 

Weighted-average shares outstanding, basic and diluted

     51,840       48,832  
  

 

 

   

 

 

 

Note Regarding Use of Non-GAAP Financial Measures

Kite provides non-GAAP net loss and non-GAAP net loss per share that include adjustments to U.S. Generally Accepted Accounting Principles (GAAP) figures. These adjustments to GAAP net loss exclude non-cash stock-based compensation expense. Kite believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Kite’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Kite’s operating results. In addition, these non-GAAP financial measures are among the indicators Kite’s management uses for planning purposes and measuring Kite’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Kite may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer below for a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

 

Page 5 of 6


KITE PHARMA, INC.

Reconciliation of GAAP to Non-GAAP Net Loss

(In thousands, except per share amounts)

(unaudited)

 

     THREE MONTHS ENDED
MARCH 31,
 
     2017     2016  

Net loss - GAAP

   $ (90,399   $ (43,916

Adjustments:

    

Non-cash stock-based compensation expense

     24,076       14,864  
  

 

 

   

 

 

 

Net loss - Non-GAAP

   $ (66,323   $ (29,052
  

 

 

   

 

 

 

Net loss per share, basic and diluted - GAAP

   $ (1.74   $ (0.90

Adjustments:

    

Non-cash stock-based compensation expense per share

     0.46       0.30  
  

 

 

   

 

 

 

Net loss per share, basic and diluted - Non-GAAP

   $ (1.28   $ (0.60
  

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     51,840       48,832  
  

 

 

   

 

 

 

KITE CONTACT:

Christine Cassiano

SVP, Corporate Communications & Investor Relations

ccassiano@kitepharma.com

Greg Mann

VP, Investor Relations

gmann@kitepharma.com

###

 

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